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Study of RO7250284 in Participants With Neovascular Age-Related Macular Degeneration (BURGUNDY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567303
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a first in-human study to investigate the safety, tolerability and efficacy of RO7250284 administered through intravitreal (IVT) injections and via the Port Delivery System in participants with neovascular age-related macular degeneration (nAMD)

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: RO7250284 Drug: Ranibizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part 1 of the study will be an open-label multiple ascending dose study, followed by subsequent assignment to 2 groups in Part 2. Part 3 will enroll new participants to compare the efficacy of RO7250284 PD implant versus ranibizumab released via the PD implant.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Part 1: Visual Acuity examiner; Part 2: Participant, Investigator and Sponsor; Part 3: Participant and Investigator
Primary Purpose: Treatment
Official Title: A Three-Part, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7250284 Following Intravitreal Administration of Multiple Ascending Doses and Sustained Delivery From the Port Delivery System in Patients With Neovascular Age-Related Macular Degeneration
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : November 19, 2025
Estimated Study Completion Date : November 19, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Part 1: Intravitreal Injections
RO7250284 administered in ascending dose levels through IVT injections.
Drug: RO7250284

Part 1: multiple ascending doses by intravitreal injection. Each participant will receive RO7250284 at a constant volume of 50 microliter in the study eye.

Part 2: participants will be randomized to one of two dose levels of RO7250284 in the PDS implant.


Experimental: Part 2: Port Delivery System with High Dose
RO7250284 administered at a high dose through the PDS implant.
Drug: RO7250284

Part 1: multiple ascending doses by intravitreal injection. Each participant will receive RO7250284 at a constant volume of 50 microliter in the study eye.

Part 2: participants will be randomized to one of two dose levels of RO7250284 in the PDS implant.


Experimental: Part 2: Port Delivery System with Low Dose
RO7250284 administered at a low dose through the PDS implant.
Drug: RO7250284

Part 1: multiple ascending doses by intravitreal injection. Each participant will receive RO7250284 at a constant volume of 50 microliter in the study eye.

Part 2: participants will be randomized to one of two dose levels of RO7250284 in the PDS implant.


Experimental: Part 3: Port Delivery System with High Dose
RO7250284 administered at a high dose through the PDS implant.
Drug: RO7250284

Part 1: multiple ascending doses by intravitreal injection. Each participant will receive RO7250284 at a constant volume of 50 microliter in the study eye.

Part 2: participants will be randomized to one of two dose levels of RO7250284 in the PDS implant.


Active Comparator: Part 3: Port Delivery System with Ranibizumab
100 mg/mL of ranibizumab administered through the PDS implant.
Drug: Ranibizumab
Participants will receive 100 mg/mL of ranibizumab through the PDS
Other Name: Lucentis




Primary Outcome Measures :
  1. Percentage of Participants with Ocular and Systemic (Nonocular) Adverse Events [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9. ]
  2. Percentage of Participants with Adverse Events of Special Interest (AESIs) including Ocular AESIs [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9. ]
  3. Percentage of Participants with Adverse Events of Special Interest (AESIs) including Ocular AESIs during the Postoperative and Follow-up periods [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9. ]
  4. Duration of Adverse Events of Special Interest (AESIs) including Ocular AESIs [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9. ]
  5. Duration of Adverse Events of Special Interest (AESIs) including Ocular AESIs during the Postoperative and Follow-up periods [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9. ]
  6. Percentage of Participants with Adverse Device Effects (ADEs) [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9. ]
  7. Duration of Adverse Device Effects (ADEs) [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9. ]
  8. Percentage of Participants with Anticipated Serious ADEs (ASADEs) [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9. ]
  9. Duration of Anticipated Serious ADEs (ASADEs) [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 12; Part 3: Baseline up to Month 9. ]
  10. Change from Baseline in Early Treatment Diabetic Retinopathy Study - Best Corrected Visual Acuity (ETDRS-BCVA) Score [ Time Frame: Part 3: Baseline (baseline visit, before implant insertion) to Week 36 ]
    ETDRS-BCVA will be used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.


Secondary Outcome Measures :
  1. Maximum Observed Concentration (Cmax) of RO7250284 in Blood and Aqueous Humor (AH) [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 36; Part 3: Baseline up to Month 36. ]
  2. Time of Maximum Concentration Observed (Tmax) of RO7250284 in Blood and AH [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 36; Part 3: Baseline up to Month 36. ]
  3. Concentration at the End of a Dosing Interval before the Next Dose Administration (Ctrough) of RO7250284 in Blood and AH [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 36; Part 3: Baseline up to Month 36. ]
  4. Area Under the Curve (AUC) of RO7250284 in Blood and AH [ Time Frame: Part 1: Baseline up to Week 24; Part 2: Baseline up to Month 36; Part 3: Baseline up to Month 36. ]
  5. Change from Baseline in Early Treatment Diabetic Retinopathy Study - Best Corrected Visual Acuity (ETDRS-BCVA) Score [ Time Frame: Part 3: Baseline (baseline visit, before implant insertion) to Week 48 ]
    ETDRS-BCVA will be used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

  6. Percentage of Participants who did not meet Supplemental Treatment Criteria for the PDS implant with RO7250284 [ Time Frame: Week 28 and Week 32 ]
  7. Percentage of Participants who Gain or Lose ≥15, ≥10 or ≥5 letters in ETDRS-BCVA score from Baseline [ Time Frame: Week 36 ]
    ETDRS-BCVA will be used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

  8. Change from Baseline in Center Point Thickness (CPT) [ Time Frame: Baseline to Week 36 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Part 1, Part 2 and Part 3 Inclusion Criteria:

  • Willing to allow AH collection.

Part 1 and Part 2 Ocular Inclusion Criteria for Study Eye:

  • Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD).
  • Anti-VEGF IVT treatment-naïve, or pre-treated with anti-VEGF no less than two months prior to Day 1.
  • Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), fundus autofluorescence (FAF), and spectral domain optical coherence tomography (SD-OCT) images.
  • Decreased best corrected visual acuity (BCVA) attributable primarily to neovascular AMD (nAMD), with BCVA letter score of 78 to 34 letters (inclusive) on early treatment diabetic retinopathy study (ETDRS)-like charts at screening. In case both eyes of a participant are eligible, the eye with the lower BCVA score should become the study eye.

Part 3 Ocular Inclusion Criteria for Study Eye:

  • CNV exclusively due to AMD.
  • Diagnosis of nAMD within nine months prior to the screening visit.
  • Previous treatment with at least two anti-VEGF IVT for nAMD.
  • Demonstrated response to prior IVT anti-VEGF treatment since diagnosis.
  • Availability of historical visual acuity (VA) data prior to the first anti-VEGF treatment for nAMD.
  • Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading.
  • BCVA letter score of 34 letters (inclusive) or better on ETDRS-like charts.

Exclusion Criteria for Study Eye:

  • History of vitrectomy surgery, submacular surgery, other intraocular surgery, or any planned surgical intervention during the study period.
  • Cataract surgery without complications within three months preceding the screening visit or planned during the study period.
  • Aphakia or absence of the posterior capsule.
  • Prior macular treatment with verteporfin, external beam radiation therapy, transpupillary thermotherapy, or any type of laser photocoagulation.
  • Prior treatment with IVT corticosteroids or implant (e.g., triamcinolone, ozurdex, iluvien).
  • Subretinal hemorrhage >50% of the total lesion area and/or involving the fovea.
  • Subfoveal fibrosis or subfoveal atrophy.
  • Retinal pigment epithelial tear involving the macula.
  • History of vitreous hemorrhage, rhegmatogenous retinal detachment, glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery, and corneal transplant.
  • History of rhegmatogenous retinal tears or peripheral retinal breaks within three months prior to the screening visit.
  • Actual or history of myopia >-8 diopters.
  • Uncontrolled ocular hypertension or glaucoma (defined as IOP >25 mm Hg or a cup to disc ration >0.8, despite treatment with antiglaucoma medication) and any such condition the Investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study.
  • Concurrent intraocular conditions (e.g., cataract, diabetic retinopathy, epiretinal membrane with traction, macular hole).

Exclusion Criteria for Fellow Eye

  • BCVA letter score using ETDRS charts of < 34 letters.
  • Treatment with anti-VEGF agents within one month prior to Day 1 (for Part 1) or prior to the randomization visit (Part 3).

Exclusion Criteria for Either Eye

  • CNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, uveitis or central serous chorioretinopathy.
  • Prior participation in a clinical trial involving anti-VEGF drugs within six months prior to the screening visit, other than ranibizumab, aflibercept, or faricimab.
  • Active intraocular inflammation (grade trace or above), infectious conjunctivitis, keratitis, scleritis, or endophthalmitis.
  • History of uveitis, including history of any intraocular inflammation following intravitreal anti-VEGF injections.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567303


Contacts
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Contact: BP41670 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, Arizona
Barnet Dulaney Perkins Eye Center Recruiting
Mesa, Arizona, United States, 85206
United States, Florida
Retina Vitreous Assoc of FL Recruiting
Saint Petersburg, Florida, United States, 33711
Southern Vitreoretinal Assoc Recruiting
Tallahassee, Florida, United States, 32308
United States, Georgia
Southeast Retina Center Recruiting
Augusta, Georgia, United States, 30909
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, New Jersey
Envision Ocular, LLC Recruiting
Bloomfield, New Jersey, United States, 07003
Mid Atlantic Retina - Wills Eye Hospital Recruiting
Cherry Hill, New Jersey, United States, 08034
United States, Tennessee
Tennessee Retina PC. Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Austin Research Center for Retina Recruiting
Austin, Texas, United States, 78705
Retina Consultants of Texas Recruiting
Bellaire, Texas, United States, 77401
Retina Consultants of Texas Active, not recruiting
Bellaire, Texas, United States, 77401
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04567303    
Other Study ID Numbers: BP41670
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents